Trial Outcomes & Findings for Conversion to Embeda With Rescue Trial (NCT NCT01179191)
NCT ID: NCT01179191
Last Updated: 2012-10-11
Results Overview
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
684 participants
Primary outcome timeframe
Baseline through Week 6
Results posted on
2012-10-11
Participant Flow
Participant milestones
| Measure |
EMBEDA
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Titration Phase (up to 6 Weeks)
STARTED
|
684
|
|
Titration Phase (up to 6 Weeks)
COMPLETED
|
351
|
|
Titration Phase (up to 6 Weeks)
NOT COMPLETED
|
333
|
|
Maintenance Phase (8 Weeks)
STARTED
|
351
|
|
Maintenance Phase (8 Weeks)
COMPLETED
|
234
|
|
Maintenance Phase (8 Weeks)
NOT COMPLETED
|
117
|
Reasons for withdrawal
| Measure |
EMBEDA
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Titration Phase (up to 6 Weeks)
Adverse Event
|
47
|
|
Titration Phase (up to 6 Weeks)
Lost to Follow-up
|
19
|
|
Titration Phase (up to 6 Weeks)
Physician Decision
|
30
|
|
Titration Phase (up to 6 Weeks)
Withdrawal by Subject
|
162
|
|
Titration Phase (up to 6 Weeks)
Participant did not reach stable dose
|
13
|
|
Titration Phase (up to 6 Weeks)
Other
|
62
|
|
Maintenance Phase (8 Weeks)
Adverse Event
|
10
|
|
Maintenance Phase (8 Weeks)
Lost to Follow-up
|
9
|
|
Maintenance Phase (8 Weeks)
Physician Decision
|
3
|
|
Maintenance Phase (8 Weeks)
Withdrawal by Subject
|
29
|
|
Maintenance Phase (8 Weeks)
Other
|
66
|
Baseline Characteristics
Conversion to Embeda With Rescue Trial
Baseline characteristics by cohort
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:few times a year(n=530)
|
46 Participants
n=5 Participants
|
|
Age Continuous
|
51.77 Years
STANDARD_DEVIATION 12.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
378 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
306 Participants
n=5 Participants
|
|
Brief Pain Inventory (BPI)
Average Pain (n = 636)
|
6.27 Units on a scale
STANDARD_DEVIATION 1.79 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Worst Pain (n = 636)
|
7.95 Units on a scale
STANDARD_DEVIATION 1.64 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Least Pain (n = 642)
|
4.63 Units on a scale
STANDARD_DEVIATION 2.27 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Relief (n = 639)
|
53.36 Units on a scale
STANDARD_DEVIATION 22.72 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
General Activity (n = 643)
|
7.01 Units on a scale
STANDARD_DEVIATION 2.33 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Mood (n = 642)
|
6.31 Units on a scale
STANDARD_DEVIATION 2.73 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Walking Ability (n = 641)
|
6.48 Units on a scale
STANDARD_DEVIATION 2.78 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Normal Work (n = 637)
|
7.21 Units on a scale
STANDARD_DEVIATION 2.48 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Relationships with Others (n = 644)
|
5.41 Units on a scale
STANDARD_DEVIATION 3.08 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Sleep (n = 642)
|
6.80 Units on a scale
STANDARD_DEVIATION 2.74 • n=5 Participants
|
|
Brief Pain Inventory (BPI)
Enjoyment of Life (n = 640)
|
7.03 Units on a scale
STANDARD_DEVIATION 2.64 • n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Low(Ir)/ Low(Pa) (n= 6)
|
6 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Low(Ir)/ Moderate (Mod)(Pa) (n= 6)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Low(Ir)/ High(Pa) (n= 6)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Mod(Ir)/ Low(Pa) (n= 1)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Mod(Ir)/ Mod(Pa) (n= 1)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: Mod(Ir)/ High(Pa) (n= 1)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: High(Ir)/ Low(Pa) (n= 1)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: High(Ir)/ Mod(Pa) (n= 1)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Abuse: High(Ir)/ High(Pa) (n= 1)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Low(Ir)/ Low(Pa) (n= 127)
|
118 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Low(Ir)/ Mod(Pa) (n= 127)
|
9 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Low(Ir)/ High(Pa) (n= 127)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Mod(Ir)/ Low(Pa) (n= 24)
|
22 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Mod(Ir)/ Mod(Pa) (n= 24)
|
2 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: Mod(Ir)/ High(Pa) (n= 24)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: High(Ir)/ Low(Pa) (n= 3)
|
2 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: High(Ir)/ Mod(Pa) (n= 3)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse General: High(Ir)/ High(Pa) (n= 3)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Low(Ir)/ Low(Pa) (n= 227)
|
208 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Low(Ir)/ Mod(Pa) (n= 227)
|
18 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Low(Ir)/ High(Pa) (n= 227)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Mod(Ir)/ Low(Pa) (n= 42)
|
38 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Mod(Ir)/ Mod(Pa) (n= 42)
|
3 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: Mod(Ir)/ High(Pa) (n= 42)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: High(Ir)/ Low(Pa) (n= 5)
|
3 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: High(Ir)/ Mod(Pa) (n= 5)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Pseudoaddiction: High(Ir)/ High(Pa) (n= 5)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Low(Ir)/ Low(Pa) (n= 295)
|
245 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Low(Ir)/ Mod(Pa) (n= 295)
|
49 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Low(Ir)/ High(Pa) (n= 295)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Mod(Ir)/ Low(Pa) (n= 56)
|
40 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Mod(Ir)/ Mod(Pa) (n= 56)
|
14 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: Mod(Ir)/ High(Pa) (n= 56)
|
2 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: High(Ir)/ Low(Pa) (n= 6)
|
3 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: High(Ir)/ Mod(Pa) (n= 6)
|
2 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Misuse Total: High(Ir)/ High(Pa) (n= 6)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Low (Ir)/ Low (Pa) (n= 487)
|
467 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Low (Ir)/ Mod (Pa) (n= 487)
|
10 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Low (Ir)/ High (Pa) (n= 487)
|
10 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Mod (Ir)/ Low (Pa) (n= 22)
|
19 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Mod (Ir)/ Mod (Pa) (n= 22)
|
2 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: Mod (Ir)/ High (Pa) (n= 22)
|
1 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: High (Ir)/ Low (Pa) (n= 5)
|
3 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: High (Ir)/ Mod (Pa) (n= 5)
|
0 Participants
n=5 Participants
|
|
Investigator(Ir) Compared to Participant(Pa)-Derived Risk Level Assessment of Misuse,Abuse,Diversion
Diversion: High (Ir)/ High (Pa) (n= 5)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:0(n=537)
|
171 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:1(n=537)
|
47 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:2(n=537)
|
53 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:3(n=537)
|
47 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:4(n=537)
|
30 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:5(n=537)
|
53 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:6(n=537)
|
28 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:7(n=537)
|
33 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:8(n=537)
|
31 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:9(n=537)
|
11 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried getting addicted or hooked to Op:10(n=537)
|
33 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:0(n=537)
|
138 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:1(n=537)
|
50 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:2(n=537)
|
67 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:3(n=537)
|
45 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:4(n=537)
|
20 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:5(n=537)
|
54 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:6(n=537)
|
26 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:7(n=537)
|
39 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:8(n=537)
|
35 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:9(n=537)
|
27 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Worried about hard time to stop Op:10(n=537)
|
36 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:tried once/twice(n=534)
|
31 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:few times a year(n=534)
|
5 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:few times a month(n=534)
|
10 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:few times a week(n=534)
|
7 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:daily(n=534)
|
5 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Chewed/crushed Op:never(n=534)
|
476 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Reason(Rn)to chew/crush Op:treat pain better(n=71)
|
35 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:treat new pain(n=71)
|
4 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:sleep better/relax(n=71)
|
14 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:help swallow drug(n=71)
|
16 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:feel pleasant/high(n=71)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:feel less depressed (n=71)
|
6 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:feel talkative/outgoing(n=71)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn to chew/crush Op:other(n=71)
|
29 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:tried once/twice(n=530)
|
75 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:few times a month(n=530)
|
116 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:few times a week(n=530)
|
58 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:daily(n=530)
|
23 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More Op than prescribed:never(n=530)
|
212 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:treat pain better(n=315)
|
274 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:treat new pain(n=315)
|
42 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:sleep better/relax(n=315)
|
48 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:feel pleasant/high(n=315)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:feel less depressed (n=315)
|
16 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use:feel talkative/outgoing(n=315)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn for more Op use: other(n=315)
|
44 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inject(inj) Op:once/twice(n=533)
|
7 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inj Op: few times a year(n=533)
|
0 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inj Op:few times a month(n=533)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inj Op:few times a week(n=533)
|
0 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inj Op:daily(n=533)
|
1 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Snort,smoke,inj Op:never(n=533)
|
523 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:treat pain better(n=37)
|
10 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:treat new pain (n=37)
|
1 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:sleep better/relax(n=37)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:feel pleasant/high(n=37)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:feel less depressed (n=37)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:feel talkative/outgoing(n=37)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-snort,smoke,inj:other(n=37)
|
28 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alcohol(Alc)use when on Op:tried once/twice(n=534)
|
32 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alc use when on Op:few times a year(n=534)
|
50 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alc use when on Op:few times a month(n=534)
|
35 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alc use when on Op:few times a week(n=534)
|
19 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alc use when on Op:daily(n=534)
|
7 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Alc use when on Op:never(n=534)
|
391 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:treat pain better(n=170)
|
10 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:treat new pain(n=170)
|
1 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:sleep better/relax(n=170)
|
21 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:enjoy occasional drink(n=170
|
91 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:feel pleasant/high(n=170)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:feel less depressed(n=170)
|
4 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:feel talkative/outgoing(n=170)
|
2 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn-Alc when on Op:other(n=170)
|
65 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More than 1 doctor (Dr) for Op:once/twice(n=529)
|
26 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More than 1 Dr for Op:sometime(n=529)
|
12 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More than 1 Dr for Op:often(n=529)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
More than 1 Dr for Op:never(n=529)
|
488 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than 1 Dr:treat pain better(n=61)
|
26 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than 1 Dr: prevent withdrawal(n=61)
|
6 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than 1 Dr:afraid to ask for more(n=61)
|
12 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than 1 Dr:feel pleasant/high (n=61)
|
1 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than 1 Dr:Dr didn't prescribed more(n=61)
|
11 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Rn- more than (>) 1 Dr:other(n=61)
|
24 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:yes (n=526)
|
35 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:yes,once(n=35)
|
5 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:yes, 2-5times(n=35)
|
24 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:yes,6-10times(n=35)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:yes, >10 times(n=35)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Gave Op to sick/in pain:no(n=526)
|
491 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Got Op from someone other than a doctor:yes(n=537)
|
43 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Got Op from someone other than a doctor:no(n=537)
|
494 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Keeps Op hidden or locked:yes(n=535)
|
373 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Keeps Op hidden or locked:no(n=535)
|
162 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:yes(n=535)
|
71 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:yes,once(n=70)
|
30 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:yes,few times(n=70)
|
29 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:yes,sometimes (n=70)
|
8 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:yes,all times (n=70)
|
3 Participants
n=5 Participants
|
|
Number of Participants Reporting Concerns With Prescription Opioid (Op) Misuse, Abuse or Diversion
Suspected someone taking Op:no(n=535)
|
464 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
|
51.3 Percentage of participants
Interval 47.5 to 55.1
|
PRIMARY outcome
Timeframe: Baseline through Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Participants were stratified based on prior opioid therapy. The 'n' is signifying those participants who were evaluated for this measure for each of the prior medication received.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Transdermal Fentanyl (n= 77)
|
54.5 Percentage of participants
Interval 42.8 to 65.9
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Immediate-release (IR) Hydrocodone (n= 164)
|
60.4 Percentage of participants
Interval 52.4 to 67.9
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
IR Hydromorphone (n= 22)
|
63.6 Percentage of participants
Interval 40.7 to 82.8
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
IR Oxycodone (n= 160)
|
48.1 Percentage of participants
Interval 40.2 to 56.2
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
IR Morphine (n= 53)
|
62.3 Percentage of participants
Interval 47.9 to 75.2
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Methadone (n= 64)
|
40.6 Percentage of participants
Interval 28.5 to 53.6
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Extended-release (ER) Oxycodone (n= 107)
|
42.1 Percentage of participants
Interval 32.6 to 52.0
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
ER Oxymorphone (n= 25)
|
56.0 Percentage of participants
Interval 34.9 to 75.6
|
|
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
Excluded Opioid/ Unclassified (n= 12)
|
8.3 Percentage of participants
Interval 0.2 to 38.5
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=351 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Duration to Titrate Participants to Stable Dose
|
20.0 Days
Standard Deviation 8.94
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=351 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Transdermal Fentanyl (n= 42)
|
17.8 Days
Standard Deviation 5.96
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
IR Hydrocodone (n= 99)
|
20.7 Days
Standard Deviation 9.13
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
IR Hydromorphone (n= 14)
|
24.3 Days
Standard Deviation 12.55
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
IR Oxycodone (n= 77)
|
19.6 Days
Standard Deviation 8.35
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
IR Morphine (n= 33)
|
18.8 Days
Standard Deviation 7.82
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Methadone (n= 26)
|
21.0 Days
Standard Deviation 8.70
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
ER Oxycodone (n= 45)
|
20.3 Days
Standard Deviation 10.55
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
ER Oxymorphone (n= 14)
|
19.8 Days
Standard Deviation 10.71
|
|
Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy
Excluded Opioid/ Unclassified (n= 1)
|
7.0 Days
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=351 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Titration Steps to Achieve Stable Dose
|
2.4 titration steps
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Safety population. Participants were stratified based on prior opioid therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies those participants who were evaluated for this measure for each of the prior medication received.
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Outcome measures
| Measure |
EMBEDA
n=351 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Methadone (n= 26)
|
2.7 titration steps
Standard Deviation 1.52
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Transdermal Fentanyl (n= 42)
|
2.0 titration steps
Standard Deviation 0.98
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
IR Hydrocodone (n= 99)
|
2.6 titration steps
Standard Deviation 1.41
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
IR Hydromorphone (n= 14)
|
2.6 titration steps
Standard Deviation 1.28
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
IR Oxycodone (n= 77)
|
2.3 titration steps
Standard Deviation 1.40
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
IR Morphine (n= 33)
|
2.3 titration steps
Standard Deviation 1.28
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
ER Oxycodone (n= 45)
|
2.4 titration steps
Standard Deviation 1.50
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
ER Oxymorphone (n= 14)
|
2.5 titration steps
Standard Deviation 1.45
|
|
Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy
Excluded Opioid/ Unclassified (n= 1)
|
1.0 titration steps
Standard Deviation NA
Standard deviation was not estimable since only one participant was evaluable.
|
SECONDARY outcome
Timeframe: Baseline through Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Rescue pain medications were used for supplemental analgesia for breakthrough pain during titration phase. Morphine sulfate IR tablet (less than 20 percent of the total daily dose of EMBEDA per IR dose), ibuprofen (up to 400 milligram (mg)/dose; not to exceed 1200 mg/day), and acetaminophen (up to 1000 mg/dose, not to exceed 4000 mg/day) were used as rescue medications.
Outcome measures
| Measure |
EMBEDA
n=650 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Percentage of Participants With Rescue Medications Usage During Titration
|
79.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Visit 3 (up to Week 6)Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. The 'n' is signifying those participants who were evaluated for the respective subscale.
BPI is an 11-item self-report questionnaire: consist of 4 questions that assess pain intensity (worst, least, average, relief) and 7 questions that assess impact of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each question answered on a scale range:0-10 (0%-100% for relief), '0=No pain/no relief/no interference and 10=Pain as bad as you can imagine/complete relief/ complete interference'.Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
Outcome measures
| Measure |
EMBEDA
n=322 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Average Pain) (n=313)
|
-2.23 Units on a scale
Standard Deviation 2.13
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Worst Pain) (n=313)
|
-2.41 Units on a scale
Standard Deviation 2.49
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Least Pain) (n=321)
|
-1.81 Units on a scale
Standard Deviation 2.33
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Relief) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (General Activity) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Mood) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Walking Ability) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Normal Work) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3(Relationships with Others) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Sleep) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
|
Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)
Change at Visit 3 (Enjoyment of Life) (n=0)
|
NA Units on a scale
Standard Deviation NA
Data for this component of BPI was not summarized as analysis plan focused on average, worst and least pain components of the BPI.
|
SECONDARY outcome
Timeframe: Week 6Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
The conversion assessment survey is a brief questionnaire using multiple choice options and numeric rating scale (NRS) with specified anchored responses ranging on a scale from 0-10 (0 = very dissatisfied, 5 = neutral, and 10=very satisfied) to assess the Investigator's level of satisfaction with the EMBEDA Conversion Guide.
Outcome measures
| Measure |
EMBEDA
n=349 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Investigator's Level of Satisfaction With the EMBEDA Conversion Guide
|
8.1 Units on a Scale
Standard Deviation 2.11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 5Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA.
Current Opioid Misuse Measure (COMM) is a 17-item self-administered test used to monitor aberrant behavior in participants on opioid therapy. Aberrant behaviors assessed using a 5-point scale \[0 = 'never' and 4 = 'very often'\]. Score range 0-68. Scores greater than or equal to 9 indicated the presence of aberrant behaviors.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants With Aberrant Behaviors
|
217 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Visit 3 (up to Week 6)Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy \[3, 4-methylenedioxyamphetamine (MDMA)\], cocaine, phencyclidine (PCP) and marijuana \[tetrahydrocannabinol (THC)\]. Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants With Abnormal Urine Drug Test Results
Baseline (n= 684)
|
160 Participants
|
|
Number of Participants With Abnormal Urine Drug Test Results
Visit 3 (n= 351)
|
101 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 3 (up to Week 6)Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Outcome measures
| Measure |
EMBEDA
n=351 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants With Urine Drug Test Results Positive for Unaccounted Opioids
|
85 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Visit 3 (up to Week 6)Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Urine samples collected were screened using immunoassay techniques for following types of drugs:opioids,barbiturates,benzodiazepines,amphetamines,ecstasy(3,4MDMA),cocaine,PCP,marijuana (THC).Quantitative, confirmatory urine drug testing performed for positive results using gas chromatography or high-pressure liquid chromatography for following analytes: morphine,oxycodone,oxymorphone,hydrocodone,hydromorphone,fentanyl,methadone,benzodiazepines,amphetamines,cocaine,THC,PCP,MDMA. Illicit substances were drugs of categories:marijuana (THC) metabolite,cocaine metabolite,PCP,amphetamine.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants With Urine Drug Test Results Positive for Illicit Substances
Baseline (n= 684)
|
51 Participants
|
|
Number of Participants With Urine Drug Test Results Positive for Illicit Substances
Visit 3 (n= 351)
|
24 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Visit 3 (up to Week 6)Population: Safety population included all participants who completed the first study visit and filled a prescription for EMBEDA. Here, the 'n' is signifying those participants who were evaluable for this measure at the specified time point for this arm group.
Urine samples collected were screened using immunoassay techniques for the following types of drugs: opioids, barbiturates, benzodiazepines, amphetamines, ecstasy (3, 4-MDMA), cocaine, PCP and marijuana (THC). Quantitative, confirmatory urine drug testing was performed for positive results using gas chromatography or high-pressure liquid chromatography, for the following analytes: morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, methadone, benzodiazepines, amphetamines, cocaine, THC, PCP, and MDMA.
Outcome measures
| Measure |
EMBEDA
n=684 Participants
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
Baseline (n= 684)
|
122 Participants
|
|
Number of Participants With Greater Than or Equal to One Urine Drug Test Results Negative for Expected Opioid
Visit 3 (n= 351)
|
11 Participants
|
Adverse Events
EMBEDA
Serious events: 24 serious events
Other events: 331 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EMBEDA
n=684 participants at risk
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Cardiac disorders
Angina unstable
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Dyspnoea
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Hyperglycaemia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Sudden death
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Skin infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Electrocardiogram t wave inversion
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Carotid artery disease
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dyskinesia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Transient ishaemic attack
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Drug abuse
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Renal failure
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
EMBEDA
n=684 participants at risk
EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.6%
18/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bradycardia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Dyspnoea
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Oedema peripheral
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Palpitations
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Syncope
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Endocrine disorders
Diabetes mellitus
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Blindness transient
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Cataract
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Diplopia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Metamorphopsia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Scleral haemorrhage
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vision blurred
|
0.88%
6/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
10/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Breath odour
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
10.8%
74/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
8/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
11/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dysgeusia
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Enteritis infectious
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Flatulence
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haematochezia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
55/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Painful defaecation
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tooth infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
33/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Adverse drug reaction
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Adverse event
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Asthenia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Burning sensation
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest discomfort
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug intolerance
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Drug withdrawal syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Face oedema
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
2.9%
20/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling abnormal
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Feeling of body temperature change
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Flushing
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Gait disturbance
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hot flush
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Hyperhidrosis
|
1.0%
7/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Influenza like illness
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Lethargy
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Oedema peripheral
|
0.88%
6/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pain
|
1.3%
9/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Thirst
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Withdrawal syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Hypersensitivity
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Immune system disorders
Urticaria
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Candidiasis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Localised infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
8/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Oral candidiasis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
6/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Rotator cuff syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Tendonitis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Intraocular pressure increased
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Gout
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Obesity
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
6/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Gout
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Restless legs syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Abnormal dreams
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Agitation
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Balance disorder
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Confusional state
|
0.73%
5/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disorientation
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Disturbance in attention
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
2.5%
17/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysaesthesia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysarthria
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysgeusia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysphemia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dysphonia
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
5.4%
37/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Insomnia
|
1.8%
12/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Restless legs syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Restlessness
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sedation
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Sinus headache
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
3.7%
25/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tension headache
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Tremor
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Urinary incontinence
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Affective disorder
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Aggression
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Crying
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Delirium
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Dysphoria
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Emotional disorder
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Enuresis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucinations, mixed
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hypersomnia
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Mood swings
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Nervousness
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Nightmare
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Throat tightness
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Hot flush
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Polymenorrhoea
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.58%
4/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.44%
3/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.29%
2/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
8/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypertension
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.15%
1/684
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER